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Regulatory Focus™ > News Articles > 2019 > 2 > Asia Regulatory Roundup: Sanofi’s ‘Brazen Defiance’ Prompts Philippines to Pull Dengue Vaccine Licen

Asia Regulatory Roundup: Sanofi’s ‘Brazen Defiance’ Prompts Philippines to Pull Dengue Vaccine License

Posted 26 February 2019 | By Nick Paul Taylor 

Asia Regulatory Roundup: Sanofi’s ‘Brazen Defiance’ Prompts Philippines to Pull Dengue Vaccine License

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Sanofi’s ‘Brazen Defiance’ Prompts Philippines to Pull Dengue Vaccine License
The Philippines Food and Drug Administration (FDA) has revoked the registration of Sanofi’s dengue vaccine Dengvaxia. FDA took the action in response to Sanofi’s “complete disregard” for its rules and regulations.
Sanofi’s landmark, but controversial, vaccine ran into trouble in 2017 when an analysis of long-term safety and efficacy data found the product increases the risk of severe dengue in people who have not previously been infected by the virus. That finding led to the suspension of Dengvaxia in the Philippines, an early buyer of the vaccine that initiated a $67 million dengue immunization program in 2016 to reduce the 200,000 cases it experiences a year.
The late-2017 suspension forced Sanofi to stop distributing the vaccine in the Philippines pending its compliance with FDA directives. One year later, FDA deemed that Sanofi had failed to comply with its directives, including the submission of post-approval commitment documents, leading it to revoke the Dengvaxia certificates of product registration (CPR) permanently and issue a damning statement about the company.
“[Sanofi’s] brazen defiance of FDA’s directives and its continued failure to comply leaves us no other recourse but to impose the maximum penalty of revocation of the CPRs covering the Dengvaxia products,” FDA director general Nela Charade Puno said.
The permanent revocation of the Dengvaxia CPRs has exposed a difference of opinion between FDA and Sanofi. While officials in the Philippines are accusing Sanofi of failing to submit the requested documents by 17 December, more than a year after the suspension began, the French pharma claims it has complied with FDA’s request.
"Sanofi Pasteur respectfully disagrees with the conclusions stated in the order and considers that the Philippines FDA has taken this decision despite our diligence, including the submission of documents from completed post-approval commitments and regular updates on the status of post-marketing studies,” the company said in a statement shared with Reuters.
The company has filed a motion for reconsideration. If that fails, Sanofi could In theory get Dengvaxia back on the market in the Philippines by reapplying for a product license. However, an FDA official has warned that Sanofi’s perceived history of noncompliance means it will be “treated as high risk.” That, coupled with the dwindling commercial prospects of Dengvaxia, could be enough to deter Sanofi.
FDA Notice, Reuters
India Advances Plan to Create Mobile Drug Testing Laboratories
India’s Drugs Consultative Committee (DCC) has backed plans to create mobile laboratories to test drugs around the country. The plans call for one mobile laboratory with the required manpower and infrastructure to be stationed in each of India’s 723 districts.
Gujarat, an Indian state, began operating a mobile testing laboratory several years ago, and the idea caught the attention of the Central Drugs Standard Control Organization (CDSCO) back in 2015. The scheme has advanced slowly since then, though. DCC created a subcommittee focused on the topic in 2017 but only heard its findings at a meeting earlier this year.
At the event, the convener of the subcommittee called for a “mobile drugs testing laboratory to be sanctioned one to each district in the country with required manpower and infrastructure and one each to CDSCO zonal and sub-zonal offices for spot testing of drug samples,” according to minutes from the meeting. India has 723 districts and CDSCO has 13 zonal and sub-zonal offices.
DCC agreed to the recommendations of the sub-committee and forwarded them to the government for consideration. The only change proposed by DCC is the elimination of one job role from the list of seven put forward by the the sub-committee. DCC accepted proposals to create mobile facilities and a central portal “for the generation of digitally signed analytical reports” without making changes.  
The proposals were discussed at a meeting that also addressed plans for all state drug testing facilities to get certified by the National Accreditation Board for Testing and Calibration Laboratories (NABL). Currently, only three state testing laboratories are NABL accredited, despite India thinking sites that comply with the standards are more efficient and deliver more trusted findings.
Having heard how NABL accreditation improves quality and accuracy, DCC agreed to the proposal to expand use of the standard to state laboratories. CDSCO thinks central laboratories can give guidance to support their state-level peers’ efforts to get accredited.
Meeting Minutes
TGA Seeks Feedback on Criteria to Support Drug Down-Scheduling
Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on criteria to support the reclassification of some prescription medicines as pharmacist only. The consultation covers Appendix M, a mechanism for applying additional controls to newly over-the-counter (OTC) medicines.
TGA thinks there is a good case for moving certain medicines from Schedule 4 to Schedule 3 (S4/S3), rendering them available OTC, but is concerned about some public health risks associated with the changes. Appendix M would help diminish those concerns by providing TGA with a way to put special controls on the use of S3 drugs in place. 
Appendix M now appears in Australia’s Poisons Standard, but the mechanism is only partly fleshed out. The consultation begun by TGA this week is intended to better define Appendix M by gauging how the industry feels about the agency’s plans.
TGA has put forward seven controls it thinks could be applicable to drugs covered by Appendix M. Three of the controls, including the need for specific pharmacist training on the use of a medicine, could be directly regulated via state and territory legislation.
The other controls “could be developed into item-specific professional practice standards.” These controls include requirements that pharmacists assess the suitability of a patient for a medicine or ask them to complete questionnaires before receiving a drug.
TGA is accepting feedback on the proposals until 1 April. The agency will then review the comments with a view to creating a final position paper. TGA plans to implement the changes by the middle of the year.
TGA Consultation
CDSCO Floats QR Codes as Solution to Track-and-Trace Logjam
CDSCO is set to seek feedback on the prospect of using quick response (QR) codes on drug packaging. DCC discussed using technology to overcome barriers to track-and-trace in India at a recent meeting.
India mandated the use of barcodes on the secondary and tertiary packaging of drug exports in 2011, but efforts to apply track-and-trace technology to the domestic supply chain have faced resistance. The government published draft rules on a proposed barcoding system in 2015, but the large number of objections it triggered meant the document was never finalized.
The idea has never gone away, though, and was given fresh impetus at a recent meeting of CDSCO’s drug consultative committee. DCC discussed how QR codes’ ability to store more information per inch than traditional barcodes could make them suitable for use on primary, secondary and tertiary packaging.
DCC thinks the idea has potential. The committee is recommending that Indian authorities get input from the industry before finalizing a mechanism for using QR codes on drug labeling and packaging. 
Meeting Minutes
Other News:
TGA has updated its advertising complaints and investigation information database to make it easier for users to find information. The changes enable users to sort complaints by factors such as risk category and receive search results based on partial word matches. TGA Notice

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